Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures-Reference-Cited by-同舟云学术

Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures

Published:2024-06-02 Issue:6 Volume:24 Page:529-542
ISSN:1471-2598
Container-title:Expert Opinion on Biological Therapy
language:en
Short-container-title:Expert Opinion on Biological Therapy

Author:

Mizoguchi Hirokuni¹²^ORCID,Fleischmann Tobias³,Komuro Masato⁴⁵,Hirai Takahiro⁶⁷,Ikeda Akiko⁸,Saito Kojiro⁷⁹,Watahiki Tomohiro⁸,Tajima Gentaro¹⁰

Affiliation:

1. Astellas Pharma Inc., Regulatory Affairs, Chuo-ku, Tokyo, Japan

2. Forum for Innovative Regenerative Medicine, Chuo-ku, Tokyo, Japan

3. Pfizer Pharma, GmbH, Biotransformation and Environmental Sciences, Berlin, Germany

4. Sanofi K.K., Regulatory Affairs, Shinjuku-ku, Tokyo, Japan

5. Japan Pharmaceutical Manufacturers Association, Chuo-ku, Tokyo, Japan

6. GlaxoSmithKline K.K., Akasaka Intercity AIR, Minato-ku, Tokyo, Japan

7. EFPIA Japan (European Federation of Pharmaceutical Industries and Associations, Japan), Shinjuku-ku, Tokyo, Japan

8. Janssen Japan K.K., Regulatory Affairs, Chiyoda-ku, Tokyo, Japan

9. Chugai Pharmaceutical Co. Ltd., Regulatory Affairs, Chuo-ku, Tokyo, Japan

10. Pfizer R&D Japan G.K., Regulatory Sciences, Shibuya-ku, Tokyo, Japan

Publisher

Informa UK Limited

Link

https://www.tandfonline.com/doi/pdf/10.1080/14712598.2024.2371042

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4. National Institute of Health Sciences. Approved gene therapy products (in Japanese). [cited 2024 Mar 22]. Available from: https://www.nihs.go.jp/mtgt/pdf/section1-1.pdf

5. Alliance for Regenerative Medicine. Available products: a comprehensive list of current cell and gene therapy products available in different markets across the world. [cited 2024 Mar 22]. Available from: https://alliancerm.org/available-products/